U.S. FDA Seeks Test Cases for Digital Health Software Precertification

As part of its effort to evaluate its precertification framework for software with medical device applications, the U.S. Food and Drug Administration (FDA) is seeking developers willing to submit “test cases” for FDA review and approval.

According to a notice posted to its website at the end of May, the FDA is seeking test cases from software organizations planning to submit a De Novo Request of a 510(k) submission for software as a medical device (SaMD). The FDA says that the test cases will give it the opportunity to evaluate and test a broad range of various SaMD products against the key components detailed in its Working Model for SaMD approvals.

Test case participants will be expected to match the FDA’s selection criteria for the program. Selected organizations must be in good standing with the FDA and possess an existing track record of developing, testing and maintaining quality software products. Selected organizations must also be willing to provide information about their quality management systems, and agree to collect and share with the agency real-world postmarket performance data.

Read the FDA’s notice for test cases for the precertification of digital health software.

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